At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 148 enrolled
Drug / intervention
derazantinibdrug
Likely dose
derazantinib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications
In Brief
A Phase 2 clinical trial evaluating derazantinib for Intrahepatic Cholangiocarcinoma and Combined Hepatocellular and Cholangiocarcinoma. Completed, enrolled 148 participants across 41 sites in 11 countries.
Detailed Summary
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, France, Germany, Ireland, Italy, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartSep 2017
Primary CompletionOct 2022
TodayJul 2026
First PostedJul 26, 2017
Enrollment StartSep 28, 2017
Primary CompletionOct 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.9 years ago
Interventions
derazantinibdrug
Derazantinib was administered orally at 300 mg once daily